Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants screened for the study but deemed low or medium risk by Khorona scoring will be offered to consent to a one time baseline blood sample. These samples will be used as the control group to establish the value of TF as a predictive marker for VTE in ambulatory cancer patients as described in the Secondary Objectives.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Participants who undergo a baseline US/CT scan and are found to have a DVT/PE will be considered a screen failure and will not be randomized and continue on in the study. In addition, if any of the screening criteria are not met, these subjects will be considered screen failures.

Reporting Groups

Description

High Risk Dalteparin Injection

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

High Risk No Therapy

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)

Low or Medium Risk Group

Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

High Risk Randomized to Dalteparin Injection

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

High Risk Randomized to No Therapy

No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)

Low Risk

Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2